CT-guided Microwave Ablation in Ground Glass Nodules

A Pilot Study to Exam the Flexibility, Safety and Efficacy of Using Microwave Ablation in Patients With Ground Glass Nodules

In order to conduct a multicenter comparative effectiveness clinical research of phase II to investigate safety and efficacy of applying microwave ablation in patients with Great-glass lung nodules ≤ 3cm, a single center, non-randomized, open label pilot study is conducted to examine the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules that are poor candidate of surgery.

Study Overview

• Status: Unknown
• Conditions: Ground Glass Nodules Less Than 3cm
• Intervention / Treatment: Procedure: CT-guided microwave ablation

Detailed Description

Lung cancer is the most common cancer worldwide contributing 13% of the total number of new cases diagnosed. The main treatments of lung cancer are based on surgical resection and adjuvant postoperative chemotherapy. However, the patients who are intolerant of surgery wouldn't be benefit from surgical resection. Microwave ablation provide new choice for lung cancer, which can effectively treat early lung cancer. The diagnosis of early lung cancer can be based on the results of biopsy of ground-glass nodules (GGNs), which is one of the diagnostic criteria for preoperative diagnosis of early lung cancer. The microwave ablation is the good choice for patients who cannot tolerate surgical resection. However, the flexibility, safety and efficacy of using Microwave Ablation in Patients with Ground Glass Nodules are still unclear.

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Bao, MD; Phone Number: 13358119776; Email: 13358119776@189.cn
• Study Contact Backup: Name: Peihua Lu, MD; Phone Number: 13621500031; Email: 13621500031@189.cn

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214023
      • Recruiting
      • Wuxi People's Hospital
      • Principal Investigator: Peihua Lu, MD
      • Contact: Jian Bao, MD; Phone Number: 13358119776; Email: 13358119776@189.cn
      • Contact: Peihua Lu, MD; Phone Number: 13621500031; Email: 13621500031@189.cn
      • Principal Investigator: Jian Bao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent, inclusive of release of medical information.
2. Age ≥ 18 years
3. CT scan indicates presence of Ground Glass Lung Nodules less than 30mm
4. Willing to comply with all protocol required follow-up: 30 days and 90 days post microwave ablation
5. Patients who cannot tolerate surgical resection due to cardiopulmonary dysfunction and advanced age
6. Patients who refuse surgical resection
7. Patients who don't have serious complications

Exclusion Criteria:

1. Unable to give informed consent or potential for noncompliance with the study protocol in the judgement of the investigator
2. Pregnant or breast-feeding at time of screening
3. Active skin infection and ulceration around the percutaneous site
4. Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis
5. Tendency of severe bleeding, platelets less than 50 × 109 / L and severe blood coagulation disorders. Anticoagulant therapy and/or antiplatelet agents should be discontinued for at least 5d-7d before microwave ablation.
6. Ablation of the ipsilateral malignant pleural effusion is not well controlled
7. Liver, kidney, heart, lung, brain dysfunction, severe anemia, dehydration and serious disorders of nutritional metabolism, cannot be corrected or improved in the short term, severe systemic infection, high fever (> 38.5 oC)
8. Extensive extrapulmonary metastasis, expected to survive < 3 months
9. Eastern Cooperative Oncology Group (ECOG) performance status > 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use CT-guided microwave ablation in Ground Glass Nodules ≤ 3cm; Patients with Ground Glass Nodules ≤ 3cm were treated with CT-guided microwave ablation	Procedure: CT-guided microwave ablation; Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited; Number of participants complied with protocol; Number of participants finished the study; Number of participants withdrew from the study	Feasibility data that help identify potential population target of CT-guided microwave ablation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events assessed by CTCAE v4.0	Safety data of CT-guided microwave ablation	6 months
Number of participants successfully removed ground glass nodules and no relapse in follow-up visit	Efficacy data of CT-guided microwave ablation	6 months
Confounding variables identified that interfere with efficacy of microwave ablation	Age, sex, medical history and ground glass nodules size examined by regression analysis	6 months

Collaborators and Investigators

• Sponsor: Wuxi People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KYLLH2018039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No